# K260948: Air Compression Massager (EP30B001 I)

- Pathway: 510(k) (Traditional)
- Applicant: Wavepulse (Xiamen) Healthcare Technology Co., Ltd.
- Decided: Jul 24, 2026 after 123 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K850316 (1985). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230500: Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401), Jiangsu Maxf Electric Appliance Co., Ltd. (2023) Summary page 5.

## Indications for use
Air Compression Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas. The Air Compression Therapy Recovery System simulates kneading and stroking of tissues by using an inflatable garment. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.

Source page: https://510kreport.com/device/K260948
Methodology: https://510kreport.com/methodology